A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587860
• Other study ID #: 132-06
• Status: Completed
• Phase: Phase 2
• First received: December 27, 2007
• Last updated: March 2, 2010
• Start date: February 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is being done to see if St. John's wort helps people with irritable bowel syndrome, otherwise known as "IBS". St. John's wort is a herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes.

Description:

Eligibility criteria:

1. Established diagnosis of IBS

2. 18-70 years of age

4) U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6) Able to participate in all aspects of the study

You will be asked to do the following:

• Undergo a screening interview and physical examination

• Take a urine pregnancy test (if applicable)

• Take a study pill twice daily for 12 weeks(3 months)

• Complete daily symptom diaries and bi-weekly questionnaires for 12 weeks.

• Complete a questionnaire at 6 months after the active phase of the study is over.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Established diagnosis of IBS

• Meet Rome II diagnostic criteria for IBS

• 18-70 years of age

• U.S. resident

• English-speaking (able to provide consent and complete questionnaires)

• Able to participate in all aspects of the study

Exclusion Criteria:

• Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, fecal incontinence, small bowel or colonic resection, pelvic floor dysfunction, paraplegia or quadriplegia)

• Current symptoms of severe depression, as measured by Center for Epidemiological Studies Depression Scale (CES-D) score

• Mental retardation or any condition requiring a legal guardian

• Current or past history of psychotic disorder (schizophrenia, bipolar disorder)

• Recent or current use (within past 30 days) of select mood or pain or symptom-altering medications:

• benzodiazepine use

• substance abuse

• narcotic use

• antihistamine use

• barbiturates

• zaleplon (Sonata)

• Recent or current use (within past 30 days) of drugs that interact with SJW:

• antidepressants or antipsychotics

• tramadol (Ultram)

• sumatriptan (Imitrex)

• digoxin (Lanoxin)

• anticonvulsants (e.g. carbamazepine or phenytoin)

• immunosuppressants: cyclosporine and tacrolimus

• HIV protease inhibitors (e.g. indinavir), non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine)

• warfarin (Coumadin)

• theophylline

• chemotherapy

• sulfa-containing drugs

• piroxicam (Feldene)

• simvastatin (Zocor)

• sibutramine (Meridia)

• verapamil (Calan or Isoptin)

• Planned surgery (especially transplant) or anesthesia exposure during trial

• Known photosensitivity or planned photodiagnostic or phototherapy procedures

• Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, and abstinence)

• Recent or current use (within 30 days) of SJW, other herbal products for IBS, investigational drug use

• Known allergy to SJW

• Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease

• Recent history of alcohol or substance dependence use or abuse

• Another household member or relative participating in the study

• Professional drivers or operators of heavy machinery

• Major cardiovascular events in the last 6 months

• Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• St. John's wort
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
• Placebo
Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Bowel Symptom Scores (BSS)	The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks).; The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.	After 12 weeks of treatment	No
Secondary	Bowel Symptom Score (BSS) Amongst Subgroups	Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.	12 weeks	No
Secondary	Adequate Relief = 50% During the Last 4 Weeks of Therapy	Participants who reported "yes" or "no" to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy.	Last 4 weeks of therapy	No
Secondary	Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score	The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.	12 weeks of treatment	No
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D) Score	We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.	12 weeks	No
Secondary	IBS Symptoms Moderately or a Lot Better	Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.	24 weeks	No
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D) Score	We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.	24 weeks	No
Secondary	Bowel Symptom Score (BSS) at 24 Weeks	The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.	24 weeks	No

External Links

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